Tai Chi Intervention for Geriatric Pain Syndrome

Chronic Pain Clinical Trial

Official title:

Tai Chi Intervention for Geriatric Pain Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03705598
• Other study ID #: 297908
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: November 2023
• Source: University of Massachusetts, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Accumulating evidence supports that more pain, whether measured by number of pain sites or pain severity, is associated with poorer cognitive function and mobility, and fall risk in older persons. Tai Chi which holistically integrates physical and cognitive functions offers the possibility not only of alleviating pain but also improving attention and mobility in the many older adults who have chronic multisite pain. This proposed full-size randomized controlled Tai Chi trial is a direct extension of our previous work examining chronic pain, attention demands, mobility and falls in the older population, and is built on the investigators' National Institute on Aging-supported Tai Chi feasibility and acceptability pilot study among older adults with multisite pain and risk for falls. The goal of this single-blinded randomized controlled trial is to examine the effects of a 24-week Tai Chi intervention on chronic pain, cognition, mobility, fear of falling, and rates of total and injurious falls in older adults with multisite pain and at risk for falls. The results of this study will provide a foundation to establish the clinical significance of Tai Chi in the management of chronic multisite pain and to explore the mechanisms through which Tai Chi improves chronic pain symptoms and lowers rates of total and injurious falls in at-risk older adults.

Description:

The investigators will measure pain severity, pain interference, pain-related biomarkers, cognition, physical function, single-task and dual-task gait, and fear of falling pre- and post-intervention in 200 older adults (Tai Chi: N=100, and exercise control: N=100). The investigators will also measure rates of total and injurious falls in the 12 months during and following the intervention. The primary aims are: 1. to examine the effects of Tai Chi on pain symptoms in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less pain, measured as pain severity and interference, than those in the light physical exercise control group; 2. to examine the effects of Tai Chi on fear of falling and rates of total and injurious falls in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have greater improvements in fear of falling scores and fewer total and injurious falls than those in the light exercise control group in the 48 weeks during and after the Tai Chi intervention. The secondary/exploratory aims are: 3. to examine the effects of Tai Chi on pain-related biomarkers in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have lower levels of pain-related biomarkers, than those in the light physical exercise control group; 4. to examine the role of improvement in chronic pain in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in fall rates are dependent on the improvement in pain symptoms in older adults with chronic multisite pain; 5. to examine the roles of improvements in cognition and mobility in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in chronic pain and in fall rates are mediated by the changes in cognition and mobility in older adults with chronic multisite pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Aged 65 years and older

2. have chronic multisite (2 or more sites) musculoskeletal pain (lasting 3 or more months in the previous year and present in the previous month)

3. reports at least 1 fall in the previous year or currently using an assistive device to walk (cane or walker)

4. Able to walk 20-feet without personal assistance

5. has never practiced Tai Chi or other mind-body exercise in the previous 5 years

6. able to communicate in English

Exclusion Criteria:

1. Actively engaged in moderate to vigorous exercise for more than 40 minutes/ week

2. Have practiced Tai Chi or other mind-body exercise within the past year

3. Practiced Tai Chi or other mind-body exercise for 3 or more months in the past 5 years

4. Physician diagnosis of any condition that might interfere with study participation including the following: unstable cardiac disease, stroke, rheumatoid arthritis, degenerative neuromuscular diseases, Parkinson's disease, terminal disease, or dementing illness

Related Conditions & MeSH terms

• Chronic Pain
• Falls

Intervention

Behavioral:
• Light physical exercise
One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm up, 30 minutes of normal walking, light intensity resistance exercise and stretching, and 20 minutes of health education discussions, supervised by a certified exercise physiologist and a research assistant.
• Tai Chi
One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm-up that included joint rotations and balance games, 45 minutes of Tai Chi practice that included Tai Chi walking drills and the 8 forms (with 12-15 minutes of breaks), and 5 minutes of cool down and breathing exercises, supervised by an experienced Tai Chi instructor and a research assistant.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Boston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity	Pain severity will be assessed using the Brief Pain Inventory.	24 weeks
Primary	Pain interference	Pain interference will be assessed using the Brief Pain Inventory.	24 weeks
Primary	Fear of falling	Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.	48 weeks
Primary	Rate of total falls	Rate of total falls will be assessed using monthly falls calendar postcards.	48 weeks
Primary	Rate of injurious falls	Rate of injurious falls will be assessed using the Abbreviated Injury Scale.	48 weeks
Secondary	Inflammatory markers	Plasma levels of C-reactive protein, interleukin 6, tumor necrosis factor alpha and Nuclear Factor kappa B will be measured using enzyme-linked immunosorbent assays.	24 weeks
Secondary	Beta endorphin	Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.	24 weeks
Secondary	Attention	Attention will be assessed by using 4 subscales of the Test of Everyday Attention.	24 weeks
Secondary	Executive function	Executive function will be assessed using the Trailmaking test, which requires the connection of sequentially numbered circles (part A), and the connection of circles marked by numbers and letters in alternating sequence (part B).	24 weeks
Secondary	Single-task gait	Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time.	24 weeks
Secondary	Dual-task gait	Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time. During the dual task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. Dual task performance and number of errors on the serial subtractions will be recorded. Coefficient of variation will be used as a measure of gait variability (SD/mean x 100). The dual task decrement, the difference between single task and dual task gait variability will be measured.	24 weeks